FDA Issues Complete Response Letter Rejecting Remoxy Approval

Remoxy contains oxycodone, a full opioid agonist, and is designed to deter abuse via non-oral routes
Remoxy contains oxycodone, a full opioid agonist, and is designed to deter abuse via non-oral routes

Pain Therapeutics announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for Remoxy (oxycodone extended-release) capsules for the management of severe pain that requires daily, around-the-clock, long-term opioid treatment and for which alternative options are inadequate. 

Remoxy contains oxycodone, a full opioid agonist, and utilizes the Company's ORADUR technology which is designed to deter abuse via non-oral routes. The FDA previously issued a CRL in 2016 stating that the NDA could not be approved in its present form and required additional studies to substantiate the claims regarding 3 routes of abuse: injection, inhalation, and snorting. Then in June 2018, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee met and voted against (14-3) the approval of Remoxy upon data review. 

In today's CRL, the FDA stated, “The data submitted in [the] NDA do not support the conclusion that the benefits of [Remoxy] Extended-Release Capsules outweigh the risks.” 

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“This is a bizarre conclusion to reach, especially during a time of staggering human and economic toll created by opioid abuse and addiction. We have an innovative drug with a social purpose, and a staggering amount of data that easily supports best-in-class abuse deterrence versus OxyContin," stated Remi Barbier, President & CEO of Pain Therapeutics. 

The Company plans on focusing its resources on Alzheimer's disease research with its lead drug candidate PTI-125 and a blood test that could potentially detect or confirm the disease even before symptoms appear (PTI-125DX). 

For more information visit PainTrials.com.